Comparing two methods for socket reconstruction and immediate dental implant placement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a national multicentric prospective randomized controlled trial that aims to compare two different bone substitute materials used during socket reconstruction and immediate implant placement. Participants will be randomly assigned to receive either deproteinized bovine bone mineral combined with hyaluronic acid or deproteinized bovine bone mineral alone. The primary outcome is to assess the increase in vertical buccal bone height following the procedures. The study will adhere to the CONSORT guidelines to ensure high-quality reporting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participant is willing and able to give informed consent for participation in the trial.
2. In good general health as evidenced by medical history.
3. Presenting a single hopeless tooth candidate for extraction in the maxillary or mandibular area (from second premolar to second premolar, intercalated or the last tooth of dental arch) in need of a single implant-supported fixed prosthetic rehabilitation.
4. Presence of \>3mm of buccal wall dehiscence evaluated using Cone Beam Computed Tomography (CBCT).
5. In healthy periodontal conditions (i.e., no presence of sites ≥ 4 mm and/or presence of intra-bony defects in the selected sites, full mouth plaque score \< 20% and full-mouth bleeding score \< 20%).

Exclusion Criteria:

1. Current or previous use of immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy.
2. Presence of inflammatory and autoimmune disease of the oral cavity.
3. Severe or poorly controlled diabetes or previous radiotherapy of head area.
4. Contraindications to dental and/or surgical interventions (e.g. severe endocrine bone diseases, severe metabolic bone disorders, malignant tumour diseases).
5. Individuals who are smokers of \>10 cigarettes/day.
6. Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
7. Presence of \<3mm of dehiscence of buccal walls of the socket after tooth extraction.
8. Presence of a distance between the interdental bone crest and buccal bone crest \<3 mm after tooth extraction.

Where it's running

• Ospedale San Raffaele
  Milan, Mi, Italy Recruiting

Study contacts

• Study coordinator: Giovanna Laura Di Domenico
• Email: giovannalauradd@gmail.com
• Phone: +393485826742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.